Full Press Release Details
Biopharma Announces IND Submission
GTB-3650 for Treatment of CD33+ Leukemia
CALIFORNIA, December 5, 2023 - GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing
innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE platform, today
announced the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for the development
of GTB-3650, a 2nd generation nanobody TriKE for the treatment of patients with CD33+ leukemia, including relapsed/refractory acute
myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
announcement is an important milestone for GT Biopharma, and we look forward to advancing GTB-3650 for treatment of CD33+ leukemia. We
are excited to expeditiously move this molecule into the clinic as we execute on our clinical objectives in 2024," stated Michael
Breen, GT Biopharma's Executive Chairman, Board of Directors and Interim Chief Executive Officer.
Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic
products based on our proprietary TriKE NK cell engager platform. Our TriKE platform is designed to harness
and enhance the cancer killing abilities of a patient's immune system's natural killer cells. GT Biopharma has an exclusive
worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE
technology. For more information, please visit gtbiopharma.com.
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